Senior Manager, Quality

Repligen; Marlborough (MA); Presencial; USD 135.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid time off

Health/Dental/Vision

Retirement benefits

Flexible spending accounts

Descripción de la vacante

HireLifeScience in Marlborough, MA is seeking a Senior Manager of Quality to strengthen quality systems, drive continuous improvement, and foster a culture of quality across the site. You will partner with global teams, lead key quality programs, and use metrics to drive data-based decisions.

The role requires 10+ years in regulated environments, 4+ years of leadership, and strong expertise in QMS, CAPA, validation, and GDP.

Formación

• Bachelor's degree in a scientific discipline is required.
• 10+ years in ISO 9001/13485 and cGMP environments.
• 4+ years of people leadership experience.
• Experience with audits, CAPA, validation, and document control.

Responsabilidades

• Maintain ISO 9001, CAPA, nonconforming material management, validation, and document control.
• Lead and develop direct reports to build a high-performing team.
• Drive quality initiatives to improve performance and compliance.
• Support enterprise-wide quality processes with global stakeholders.
• Develop and communicate quality metrics and KPIs.
• Lead internal and external audit programs and CAPA actions.
• Oversee risk-based investigations and deviation management.
• Identify continuous improvement opportunities and digitalisation efforts.
• Collaborate on product release activities and operational priorities.
• Balance strategic priorities with day-to-day execution.

Conocimientos

QMS Auditing

Leadership

Cross-functional collab

CAPA Processes

Root Cause Analysis

GDP Knowledge

Lean Methods

Risk Management

Educación

Bachelor's degree in Chemistry/ Biology/ Engineering

Descripción del empleo

The Senior Manager, Quality is a leadership role focused on strengthening quality systems, driving continuous improvement, and supporting a culture of quality across the Marlborough site. Working across functions and partnering with global quality teams, this role will lead key quality programs, use metrics to identify opportunities for improvement, and help advance initiatives that enhance compliance, efficiency, and the overall employee and customer experience.

Responsibilities

• Maintain compliance with ISO 9001 and applicable quality requirements across all aspects of the Quality Management System, including internal and external audits, CAPA, nonconforming material management, validation activities, and document control.
• Lead, mentor, and develop direct reports, fostering a high-performing team culture built on accountability, collaboration, and continuous learning.
• Drive quality excellence initiatives that strengthen quality culture, improve organizational effectiveness, and support long-term business objectives.
• Partner with site leadership and global quality stakeholders to support the continued development and implementation of enterprise-wide quality management processes.
• Develop, monitor, analyze, and communicate quality metrics and KPIs to assess organizational quality health, identify trends and drive data-based decision making.
• Lead or support internal and external audit programs, ensuring timely execution, effective root cause analysis, and completion of corrective and preventive actions.
• Oversee document control processes and ensure quality procedures, policies and records remain compliant, effective and current.
• Provide quality oversight for investigations, deviations, nonconforming materials, out-of-specification results, and CAPA activities, ensuring appropriate risk assessment and resolution.
• Identify and implement continuous improvement opportunities that increase efficiency, strengthen compliance, and enhance overall quality system effectiveness.
• Champion strategic quality projects, including digital transformation initiatives such as the transition from paper-based quality documentation and certificates to electronic quality systems.
• Collaborate effectively with cross-functional teams to support product release activities, operational priorities, and broader business initiatives.
• Utilize risk-based decision making to maintain compliance while enabling business success.

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
• Minimum of 10 years of experience within an ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment.
• Minimum of 4 years of people leadership experience, including coaching, mentoring and developing direct reports.
• Demonstrated expertise in Quality Management Systems, auditing, CAPA, document control, validation, and nonconforming material processes.
• Strong knowledge of Good Documentation Practices (GDP), root cause analysis methodologies, and quality investigation processes.
• Experience developing, tracking, and reporting quality metrics to drive performance and continuous improvement.
• Proven ability to lead cross-functional initiatives and influence stakeholders at multiple levels of the organization.
• Strong organisational, problem-solving, and project management skills, with the ability to balance strategic priorities and day-to-day execution.
• Experience leading quality system improvements, transformation initiatives or digitalisation projects preferred.
• Lean, continuous improvement, or operational excellence experience preferred.
• Excellent communication, collaboration and relationship-building skills.
• Demonstrated commitment to fostering a positive quality culture and developing high-performing teams.

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $135,000-$190,000. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programmes (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.

This role is expected to model our Leadership Behaviours-Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment and Accountability & Results in all aspects of work.